Senior Medical Director, Hematology Clinical Development
$182,000–$346,000 year
HybridNorth Chicago, Illinois, United States
Job Summary
Manage the design, implementation, and oversight of one or more clinical development programs, ensuring adherence to Good Clinical Practices, regulatory requirements, and global drug development standards. Direct the review, interpretation, and communication of accumulating data regarding safety and efficacy, while overseeing study enrollment, timelines, and serious adverse event reporting. Lead cross-functional teams to generate high-quality clinical data supporting product strategy, including the development of protocols, Investigator Brochures, and regulatory submissions. Provide in-house clinical expertise for the molecule and disease area, acting as a clinical interface to solicit opinion leader interactions and coordinate with Medical Affairs and Commercial functions. Supervise Medical Directors and Clinical Scientists, potentially chairing a Clinical Strategy Team to develop vetted development plans with full contingency consideration. Stay abreast of professional information through conferences and literature to augment therapeutic area expertise.
Required Qualifications
- Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment
- Completion of a residency program
- At least 2 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent
- Ability to run a clinical research program of moderate complexity with minimal supervision
- Ability to perform and bring out the best in others on a cross-functional global team
- Ability to interact externally and internally to support a global scientific and business strategy
- Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols
- Must possess excellent oral and written English communication skills
Desired Qualifications
- Completion of a subspecialty fellowship
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